ADHDPhase 3NCT00507065
Safety and Efficacy of ADDERALL XR in the Treatment of Adolescents Aged 13-17 With Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 3 study testing Mixed salts of a single-entity amphetamine (ADDERALL XR) in people with ADHD, run by Shire at 1 site in United States.
Trial summary
Assess the safety and efficacy of ADDERALL XR compared to placebo in the treatment of adolescents (aged 13-17) with ADHD. Subjects were assigned to one of two cohorts based on weight (<= 75 kg or > 75 kg). Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- ADHD
- What is being tested?
- Mixed salts of a single-entity amphetamine (ADDERALL XR)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 329 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2003to 24 Mar 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males/females 13-17 years of age meeting DSM-IV criteria for a primary diagnosis of ADHD
Who cannot join
- Controlled or uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms such as PTSD, psychosis, bipolar disease, severe OCD
- Known non-responder to stimulant medication
- Documented allergy or intolerance to ADDERALL, ADDERALL XR or amphetamines
- Conduct Disorder, hypertension, history of seizure
- Tic disorder or Tourette's disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University - Child Study Center
New York, New York
About this study
Official title: A Phase III, Randomized, Multicenter, Double-blind, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of ADDERALL XR With an Open Label Extension, in the Treatment of Adolescents Aged 13-17 With ADHD
Assess the safety and efficacy of ADDERALL XR compared to placebo in the treatment of adolescents (aged 13-17) with ADHD. Subjects were assigned to one of two cohorts based on weight (<= 75 kg or > 75 kg).
- Conditions
- ADHD
- Being tested
- Mixed salts of a single-entity amphetamine (ADDERALL XR), Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed salts of a single-entity amphetamine (ADDERALL XR)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Adderall XR (10 mg) | Experimental | Not described Receives: Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR) |
| Adderall XR (20 mg) | Experimental | Not described Receives: Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR) |
| Adderall XR (30 mg) | Experimental | Not described Receives: Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR) |
| Adderall XR (40 mg) | Experimental | Not described Receives: Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR) |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to final visit of the double-blind phase of the study in the ADHD-RS-IV score in the cohort weighing less than or equal to 75 kg.
Measured: approximately 4 weeks
Secondary outcomes (2)
Change from baseline to final visit of double-blind phase of the study in ADHD-RS-IV score in the cohort weighing >75 kg and the CGI for ADHD in both cohorts.
Measured: Approximately 4 weeks
Adverse events, labs, physical exam, ECG
Measured: approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study start28 May 2003
- Primary completion24 Mar 2004
- Study completion24 Mar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507065
- Sponsor's protocol ID
- SLI381-314A
- Status last verified
- Jun 2021
- First submitted
- 19 Jul 2007
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Spencer TJ, Wilens TE, Biederman J, Weisler RH, Read SC, Pratt R. Efficacy and safety of mixed amphetamine salts extended release (Adderall XR) in the management of attention-deficit/hyperactivity disorder in adolescent patients: a 4-week, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2006 Feb;28(2):266-79. doi: 10.1016/j.clinthera.2006.02.011.
PubMed 16678648
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Multicenter, Double-blind, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of ADDERALL XR With an Open Label Extension, in the Treatment of Adolescents Aged 13-17 With ADHD
- ClinicalTrials.gov ID
- NCT00507065
- Acronym / sponsor ID
- SLI381-314A
- Conditions
- ADHD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 28 May 2003 (actual)
- Primary completion
- 24 Mar 2004 (actual)
- Study completion
- 24 Mar 2004 (actual)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the safety and efficacy of ADDERALL XR compared to placebo in the treatment of adolescents (aged 13-17) with ADHD. Subjects were assigned to one of two cohorts based on weight (<= 75 kg or > 75 kg).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Adderall XR (10 mg) | Experimental | Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR) |
| Adderall XR (20 mg) | Experimental | Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR) |
| Adderall XR (30 mg) | Experimental | Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR) |
| Adderall XR (40 mg) | Experimental | Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR) |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Males/females 13-17 years of age meeting DSM-IV criteria for a primary diagnosis of ADHD
Key exclusion criteria (5 listed)
- Controlled or uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms such as PTSD, psychosis, bipolar disease, severe OCD
- Known non-responder to stimulant medication
- Documented allergy or intolerance to ADDERALL, ADDERALL XR or amphetamines
- Conduct Disorder, hypertension, history of seizure
- Tic disorder or Tourette's disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixed salts of a single-entity amphetamine (ADDERALL XR) | Drug | Adderall XR (10 mg), Adderall XR (20 mg), Adderall XR (30 mg), Adderall XR (40 mg) |
| Placebo | Drug | placebo |
Primary outcome
Change from baseline to final visit of the double-blind phase of the study in the ADHD-RS-IV score in the cohort weighing less than or equal to 75 kg.
Time frame: approximately 4 weeks
2 secondary outcomes
Change from baseline to final visit of double-blind phase of the study in ADHD-RS-IV score in the cohort weighing >75 kg and the CGI for ADHD in both cohorts.
Time frame: Approximately 4 weeks
Adverse events, labs, physical exam, ECG
Time frame: approximately 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Results publication: PubMed 16678648Spencer TJ, Wilens TE, Biederman J, Weisler RH, Read SC, Pratt R. Efficacy and safety of mixed amphetamine salts extended release (Adderall XR) in the management of attention-deficit/hyperactivity disorder in adolescent patients: a 4-week, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2006 Feb;28(2):266-79. doi: 10.1016/j.clinthera.2006.02.011.
- FDA Recall informationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mixed salts of a single-entity amphetamine (ADDERALL XR) in people with ADHD, run by Shire at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to final visit of the double-blind phase of the study in the ADHD-RS-IV score in the cohort weighing less than or equal to 75 kg. (time frame: approximately 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00507065, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.